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FDA Mandatory Regulations for Breast Cancer Screening

Volpara Health – Updated on March 10, 2021

The US Food and Drug Administration (FDA) is moving to improve the quality of mammography and provide more health information to patients, especially in the area of breast density, which is a target of Volpara’s specialised analytics.

The FDA’s proposed amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA).

In October the FDA stated that its proposed amendments are aimed at addressing changes in mammography technology and processes that have occurred since the regulations were published in 1997, and will address breast density reporting to patient and health care providers.

The FDA’s update aims to capitalise on important advances such as the wider use of digital imaging devices, revised screening recommendations, the need for more uniform nationwide breast density reporting and the increasing clinical value of breast density information.

“We believe this proposal will have significant health benefits given its potential to provide women and health care providers with more consistent, comprehensive, scientifically relevant information about mammography results,” FDA Commissioner Scott Gottlieb MD said.

“Mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact medical device innovations have on supporting women’s health.”

The FDA also says that modernising mammography oversight will strengthen its ability to enforce consistent quality standards for mammograms.

The FDA believes that public health benefits will be substantial, including the potential for early breast cancer detection, improved morbidity and mortality, reduced cancer treatment costs and more informed decision-making by patients and their providers.